DAPAGLIFLOZIN PROPANEDIOL for Chronic kidney disease

Inclusion criteria

• {"criterion_text":"-\tSigned informed consent\n-\t≥ 18 years of age\n-\tFor those not undergoing dialysis: o\tChronic Kidney Disease (CKD), defined as evidence of decreased eGFR (eGFR >=20 and <60 mL/min/1.73 m2) at least 3 months before and at the time of screening or evidence of albuminuria present for > 3 months if eGFR >60\n-\tFor those undergoing hemodialysis: Initiation of hemodialysis within 1 year of the randomization visit\n-\tStable treatment with clinically appropriate doses of ACEi/ARB among CKD patients with proteinuria, if not medically contraindicated\n-\tFor patients with type 2 diabetes: o\tStable antihyperglycemic treatment > 30 days before screening\n-\tFemale patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device\n-\tAbility to understand and read Danish"}

Exclusion criteria

• {"criterion_text":"-Type 1 diabetes\n-•\tFor dialysis participants: Known hepatic impairment documented in the participants electronic health record\n-Known blood-borne diseases, such as Hepatitis A, B, C, D, and E, and Human immunodeficiency virus (HIV) types 1 and 2, Ebola, Lassa fever virus.\n-For patients with type 2 diabetes: o\tHistory of diabetic ketoacidosis\n-History of organ transplant\n-Treatment with SGLT2 inhibitor within 8 weeks (not undergoing dialysis) or 4 weeks (undergoing dialysis) prior to enrolment\n-Known allergy or hypersensitivity to SGLT2 inhibitors or Placebo ingredients\n-Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks of enrolment\n-Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment\n-Any condition outside the renal and cardiovascular study area with a life expectancy of <2 years based on investigator’s clinical judgement\n-For non-dialysis participants: Hepatic impairment (aspartate transaminase or alanine transaminase >3 times the upper limit of normal [ULN] or total bilirubin >2 times the ULN at the time of enrolment)"}

Primary endpoints

• {"endpoint_text":"- Change in LV mass index assessed by echocardiography at 6 months","definition_or_measurement_approach":"Assessed by echocardiography at 6 months (change from baseline)."}

Secondary endpoints

• {"endpoint_text":"- Change in LV ejection fraction at 6 months\n- Change in global longitudinal strain at 6 months\n- Change in LV end-diastolic volume at 6 months\n- Change in LV end-systolic volume at 6 months\n- Change in left atrial volume index at 6 months\n- Change in creatinine/eGFR at 6 months\n- Change in UACR at 6 months\n- Change in haemoglobin at 6 months\n- Change in proBNP at 6 months\n- Change in Troponin at 6 months\n- Change in LV mass at 6 months","definition_or_measurement_approach":"Each endpoint measured as change from baseline to 6 months (echocardiographic measures for cardiac endpoints; laboratory measures for creatinine/eGFR, UACR, haemoglobin, proBNP, Troponin)."}

Denmark

Earliest CTIS Part Ii Submission Date

07-10-2024

Latest Decision Or Authorization Date

29-01-2025

Processing Time Days

114

Number Of Sites

2

Number Of Participants

260

Primary sponsor

Full Name

Gentofte Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Health care"}